2003 Warning Letters

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Warning Letters issued in 2003

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 

Posted on May 05, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 29, 2003	Cherry Point Seafood Company, Inc.	Atlanta District Office	Seafood HACCP/Adulterated	N/A *
September 29, 2003	Organon USA Inc.	New Jersey District Office	GMP Finished Pharmaceuticals/Postmarketing/Reporting Adverse Drug Experiences/Adulterated	N/A *
September 26, 2003	Westfalia-Surge, Inc.	Chicago District Office	GMP for Finished Pharmaceuticals, Veterinary Drug/Adulterated	N/A *
September 26, 2003	Greenvalley, LLC	New York District Office	New Drug/False, Misleading Statements/Misbranded	N/A *
September 26, 2003	Horn's Feed Mill, Inc.	Chicago District Office	Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded	N/A *
September 26, 2003	Target Your Health, Inc.	Center for Biologics Evaluation and Research	Lacks Approved Biologics License Application/New Drug/Use of Ruminant Products	N/A *
September 26, 2003	LifeSouth Community Blood Centers, Inc.	New Orleans District Office	GMP for Finished Pharmaceuticals/GMP for Blood & Blood Components	N/A *
September 25, 2003	America's Soup Company, Inc.	New Jersey District Office	Seafood HACCP/Adulterated	N/A *
September 25, 2003	Community Blood Bank of Erie	Philadelphia District Office	GMP for Blood & Blood Components/Finished Pharmaceuticals	N/A *
September 25, 2003	Ontonagon Memorial Hospital	Detroit District Office	Mammography Quality Standards	N/A *
September 24, 2003	Consolidated Machine Corporation	New England District Office	Lacks Premarket Approval, Investigational Device Exemption/QSR/Misbranded/Adulterated	N/A *
September 24, 2003	Pride of Main Street Dairy LLC	Center for Food Safety and Applied Nutrition	Food Labeling/Misbranded	N/A *
September 23, 2003	Chinle Comprehensive Health Care Facility	Los Angeles District Office	Mammography Quality Standards	N/A *
September 23, 2003	International Fine Foods	Minneapolis District Office	Seafood HACCP/Adulterated	N/A *
September 23, 2003	Garland Welding Supply Co. Inc.	Dallas District Office	GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated	N/A *
September 23, 2003	Universal Imaging Inc.	Detroit District Office	Mammography Quality Standards	N/A *
September 23, 2003	Susie-Q Fish Company, Inc.	Minneapolis District Office	Seafood HACCP/Adulterated	N/A *
September 23, 2003	Henriksen Fisheries, Inc.	Minneapolis District Office	Seafood HACCP/Adulterated	N/A *
September 19, 2003	Con-Cise Lens Company	San Francisco District Office	Quality System Regulation/Adulterated	N/A *
September 18, 2003	R&K Livestrock	Dallas District Office	Illegal Drug Residue/Animal Tissue/Adulterated	N/A *

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